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getemed PhysioMem PM 100 4G Instructions For Use Manual

Tele-ecg event recorder
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Instructions for Use
PhysioMem
PM 100 4G
®
Tele-ECG Event Recorder
Revision 03 EN
Cardiac Diagnostics
Vital Signs Monitoring
Telemonitoring

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Summary of Contents for getemed PhysioMem PM 100 4G

  • Page 1 Instructions for Use PhysioMem PM 100 4G ® Tele-ECG Event Recorder Revision 03 EN Cardiac Diagnostics Vital Signs Monitoring Telemonitoring...

  • Page 3: Table Of Contents

    Charging the Battery ..............23 How to apply the Device ............26 Recording an ECG ..............28 Automatic Transmission ............29 PhysioMem PM 100 4G and ReSTA .......... 32 ECG Report..................33 Patient Information ................35 Disposal of Device and Accessories..........36 Troubleshooting .................

  • Page 4: Information About This Manual

    Oderstr. 77, 14513 Teltow, Germany www.getemed.de The information provided in this manual applies to PhysioMem PM 100 4G, version 2.x.x. It does not apply to earlier versions. Adobe Acrobat and Reader are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.

  • Page 5: Intended Purpose

    ReSTA from GETEMED. The device is intended for patient activated record- ings. The PM 100 is intended to be used in both home environ- ments and clinical environments.

  • Page 6: Regulatory Information

    Class IIa Protection against electric shock Type CF (Cardiac Floating), non- defibrillation-proof applied part Mode of operation Continuous Method(s) of sterilization recom- Not applicable mended by the manufacturer Use classification Multiple patients multiple use PhysioMem PM 100 4G 77814021 - EN...

  • Page 7: Labelling

    Symbol "Distributor" Next to the symbol is the name and the address of the distributor. Symbol "Country of origin" "DE" indicates that the product is made in Germany. MADE IN GERMANY Country of origin 77814021 - EN PhysioMem PM 100 4G...
  • Page 8 Symbol "Unique Device Identifier" UDI Label; matrix code with GTIN (01), date of manufacturing (11), device identi- fier [SN] (21) and device catalogue number (01) 04250903202513 [REF] (241) (11) 201121 (21) 8401400001 (241)77214001 PhysioMem PM 100 4G 77814021 - EN...

  • Page 9: Safety Information

    Use to indicate hazards and the degree of severity. A hazard is defined as a potential source of harm, harm being de- fined as injury or damage to the health of people, or damage to property or the environment. 77814021 - EN PhysioMem PM 100 4G...

  • Page 10: General Warning Notes

    Use protective gloves to handle the equipment.  Isolate the material by using suitable packaging  and labeling. Contact the addressee before sending the  equipment. Clean the device and accessories after every  use. PhysioMem PM 100 4G 77814021 - EN...
  • Page 11 NOT A MONITORING DEVICE The PhysioMem PM 100 4G is not a monitoring device and is not intended for monitoring the clinical condition of a patient. Do NOT use the PhysioMem PM 100 4G as a monitoring device. WARNING EXPLOSION HAZARD Electrical sparks can cause explosions in the presence of certain gases.

  • Page 12: General Precautions

    Otherwise, the correct functioning of the device can no longer be guaranteed. CAUTION MALFUNCTION Do not use the device if it has been damaged or has mal- functions. PhysioMem PM 100 4G 77814021 - EN...
  • Page 13 If the device is not in use, switch it off and store it with care to prevent accidental activation. This could result in incorrect ECG interpretation. Also, switch off the device before shipping to prevent inadvertent data transmis- sion. 77814021 - EN PhysioMem PM 100 4G...

  • Page 14: Incident Reporting

    A serious incident is a device malfunction that results in death or serious injury, or may lead to death or serious deterioration in state of health of an individual. PhysioMem PM 100 4G 77814021 - EN...

  • Page 15: Warranty And Service Information

    Please add a detailed error description. If you determine an unexpected operational condition or unex- pected occurrences or if you need technical support, contact the manufacturer under the following address: GETEMED Medizin- und Informationstechnik AG Oderstr. 77, 14513 Teltow, Germany www.getemed.de Cleaning and Disinfection Clean and disinfect the device at regular intervals, prior to first use and before passing it on to another person.
  • Page 16 GETEMED recommends to use a 70 % alcohol solution for disin- fection. Please note the application time of the disinfectant (10 minutes for 70 % alcohol solution). Subsequently use a lint-free cloth slightly moistened to remove remainders of the disinfectant.

  • Page 17: Operation

    (Figure 1). Figure 1 - Pushbutton and display The four electrodes for the ECG lead are positioned on the back of the device (Figure 2). Figure 2 - Electrodes 77814021 - EN PhysioMem PM 100 4G...

  • Page 18: Visual And Acoustic Signals

    Charging of the battery required - recording possible, transmission not possible until the battery is recharged until 20 % capacity Battery exhausted. Recording not possible until the battery is recharged until 20 % ca- pacity PhysioMem PM 100 4G 77814021 - EN...
  • Page 19 Button pressed (recording started) 1 x beep Recording in progress 1 single beep on every recognized heart beat 77814021 - EN PhysioMem PM 100 4G...
  • Page 20 ReSTA server Battery charging has started 2 x short beep Battery charging in progress (battery symbol is changing) Error (see section "Troubleshooting" 3 x short beep in this manual for more information) PhysioMem PM 100 4G 77814021 - EN...

  • Page 21: Lead Scheme

    When the startup process has finished the device establishes a connection to the ReSTA server and sends a status message that contains the memory and battery status (Figure 5). Settings, date and time are synchronized with the ReSTA server. 77814021 - EN PhysioMem PM 100 4G...
  • Page 22 Ensure that the device is always ready for use and only switch it off if you will not use it for a longer time, e. g. on an airplane or if a reset becomes necessary. PhysioMem PM 100 4G 77814021 - EN...

  • Page 23: Charging The Battery

    Use the USB cable to connect the charging pad to the power adaptor and connect the power adaptor to the mains supply. The green LED is shining as soon as the charging pad is con- nected to the power supply system (Figure 8). 77814021 - EN PhysioMem PM 100 4G...
  • Page 24 A short double beep will sound once the device is placed on the charging pad. The short double beep will also sound if the device is switched on while it is on the charging pad. The orange LED PhysioMem PM 100 4G 77814021 - EN...
  • Page 25 LED is shining (Figure 12). Figure 12 - Charger Pad - not charging NOTICE If the ambient temperature is lower than 0 °C the device should not be charged. 77814021 - EN PhysioMem PM 100 4G...

  • Page 26: How To Apply The Device

    The manufacturer recommends always wearing the device by means of the included neck lanyard. In this way, no time is lost when an ECG is to be recorded. PhysioMem PM 100 4G 77814021 - EN...
  • Page 27 Figure 14 - Device positioned on the chest WARNING STRANGULATION BY THE NECK LANYARD – Neck lanyards present a possible strangulation risk. Do not wear the de- vice with the neck lanyard around your neck while you are sleeping. 77814021 - EN PhysioMem PM 100 4G...

  • Page 28: Recording An Ecg

    When the beep fails dur- ing recording carefully correct the position of the device and press it more firmly on the chest. In case of strong chest hair PhysioMem PM 100 4G 77814021 - EN...

  • Page 29: Automatic Transmission

    15 cm away from their implanted device after the recording. Pa- tients with pacemakers or ICDs must not use the supplied neck lanyard to carry the device. 77814021 - EN PhysioMem PM 100 4G...
  • Page 30 1st attempt immediately after the failed transmission  Three attempts every 15 minutes  One attempt after 5 hours  Further attempts every 24 hours  PhysioMem PM 100 4G 77814021 - EN...
  • Page 31 Connection of additional components Disconnection of components from the network  Update of components connected to the network  could cause new risks that require additional analysis. Refer to the standard EN 80001. 77814021 - EN PhysioMem PM 100 4G...

  • Page 32: Physiomem Pm 100 4G And Resta

    ECG data (Figure 19). Figure 19 - PhysioMem PM 100 4G and ReSTA In ReSTA the device ID of each PhysioMem PM 100 4G is assigned to a corresponding target address (email, URL). The patient (1) makes a recording (2) that will be transmitted automatically to the ReSTA server via mobile network (3).

  • Page 33: Ecg Report

    25 mm/s and an amplitude of 10 mm/mV. The heart rate in beats per minute [bpm] and [ms] is continuously calculated from the time that elapses between two consecutive beats. Averaging is not used for the calculation. 77814021 - EN PhysioMem PM 100 4G...
  • Page 34 The recording and transmission times refer to Central Euro- pean Time or Central European Summer Time (CET or CEST). NOTICE In case of loss of the device immediately contact your distributor or the manufacturer. PhysioMem PM 100 4G 77814021 - EN...

  • Page 35: Patient Information

    Medical Emergency The device is not intended to detect life-threatening events. In- struct the patient to call a doctor or emergency services immediately if he/she feels unwell in the state of his/her health. 77814021 - EN PhysioMem PM 100 4G...

  • Page 36: Disposal Of Device And Accessories

    If you have any questions regarding the disposal of the product, do not hesitate to contact the manufacturer or its representa- tives. PhysioMem PM 100 4G 77814021 - EN...

  • Page 37: Troubleshooting

    Restart the device. Press the but- ton until the device is power off. Then press the button to restart the device. If a restart does not solve the problem, contact the service of the manufacturer. 77814021 - EN PhysioMem PM 100 4G...

  • Page 38: Common Problems

    ECG data cannot Device has not been Contact the service of the be transmitted activated by the manu- manufacturer. but mobile net- facturer. work connection has been estab- lished. PhysioMem PM 100 4G 77814021 - EN...
  • Page 39 No display / Malfunction possibly Switch off the device and caused by strong elec- switch it on again. Check irregular tromagnetic interfer- the operation environment Display. ence. for sources of strong elec- tromagnetic fields. 77814021 - EN PhysioMem PM 100 4G...

  • Page 40: Information Regarding Consumables And Accessories

    14 Information regarding Consumables and Accessories Part REF number PhysioMem PM 100 4G Tele ECG Event Recorder 77214001 Wireless Charging Transmitter Pad 77442301 Power supply for wireless charging transmitter pad 77441101 USB cable for wireless charging transmitter pad 77412001 Neck lanyard...

  • Page 41: Specifications

    15 Specifications 15.1 PhysioMem PM 100 4G – General Recording channels 2 channels ECG leads 2 leads, 4 metal electrodes Recording time 40 s (default), 60 s, 90 s, 120 s Lead off detection Pacemaker detection Display 1 LCD display...

  • Page 42: Wireless Charging Pad - General

    15.3 Operating conditions Temperature range 5 °C ... 45 °C Relative humidity 10 % ... 95 %, non-condensing 106 kPa … 50 kPa Ambient pressure 106 kPa … 80 kPa (power supply) PhysioMem PM 100 4G 77814021 - EN...

  • Page 43: Transport And Storage Conditions

    Class A lishments and those di- IEC 61000-3-2 rectly connected to the public low-voltage power Voltage fluctuations / Complies supply network that sup- Flicker emissions plies buildings used for do- IEC 61000-3-3 mestic purposes. 77814021 - EN PhysioMem PM 100 4G...
  • Page 44 70 % UT; 25/30 the device be powered 70 % UT; cycles from an uninterruptible 25/30 cycles Single phase: power supply or a bat- Single phase: at 0° tery. at 0° PhysioMem PM 100 4G 77814021 - EN...
  • Page 45 61000-4-3 2,7 GHz according to in the vicinity of equip- Immunity against table 9** ment marked with the wireless RF com- following munication devices symbol: *) = Specifications according to IEC 60601-1-2: 2014 77814021 - EN PhysioMem PM 100 4G...
  • Page 46 TETRA 800, iDEN 820, 18 Hz CDMA 850, LTE Band 5 1720 1700 – GSM 1800; Pulse 1845 1990 CDMA 1900; modulation 1970 GSM 1900; DECT; 217 Hz LTE Band 1, 4, 25; UMTS PhysioMem PM 100 4G 77814021 - EN...
  • Page 47 If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 77814021 - EN PhysioMem PM 100 4G...
  • Page 48 30 cm to any part of the de- vice, including cables specified by the manufacturer. Oth- erwise, degradation of the performance of this equipment could result. PhysioMem PM 100 4G 77814021 - EN...

  • Page 49: List Of Figures

    Figure 16 - Recording in progress ............. 28 Figure 17 - Battery exhausted ..............29 Figure 18 - Automatic Transmission ............30 Figure 19 - PhysioMem PM 100 4G and ReSTA ......... 32 Figure 20 - ECG Report................33 77814021 - EN...
  • Page 52 GETEMED Medizin- und Informationstechnik AG Oderstr. 77 / 14513 Teltow / Germany Telephone: +49 (0)3328 / 3942-00 Telefax: +49 (0)3328 / 3942-99 Revision 03 EN / 2023-05-03 info@getemed.de / www.getemed.de...

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